| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| BIO-HRR-PANEL | ATM germline pathogenic | IIA | ATM germline pathogenic confers ~2× lifetime breast-cancer risk; no PARPi indication (TBCRC-048 ATM cohort showed minimal activity). Standard breast- cancer therapy by ER/HER2 status. ESCAT IIA (predisposition) / OncoKB Level 3A. Avoid radiotherapy in homozygous/biallelic ATM (radiosensitivity). | standard breast therapy by HR/HER2 enhanced screening (annual MRI) |
| |
| BIO-HRR-PANEL | BARD1 germline pathogenic | IIA |
| BARD1 germline pathogenic confers moderate breast-cancer risk (~2-3×). BARD1 forms heterodimer with BRCA1 → biological HR deficiency. Limited clinical PARPi data; off-label consideration. ESCAT IIA / OncoKB Level 3A. | standard breast therapy olaparib off-label (HRR rationale) |
|
| BIO-HRR-PANEL | BRIP1 germline pathogenic | IIIA |
| BRIP1 germline pathogenic and breast cancer: weak/uncertain risk association (NCCN does not currently recommend enhanced breast surveillance based on BRIP1 alone). No PARPi indication. ESCAT IIIA / OncoKB Level 3B. | standard breast therapy by subtype |
|
| BIO-HRR-PANEL | CHEK2 germline pathogenic | IIA |
Evidence cited from clinical guidelines; per-source evidence levels not yet structured. See Phase-2-of-CIViC-pivot for re-cite roadmap. | CHEK2 germline pathogenic (e.g. 1100delC) confers ~2× breast-cancer risk; no PARPi activity demonstrated (TBCRC-048 CHEK2 cohort minimal response). Standard HR/HER2-directed therapy. ESCAT IIA (predisposition) / OncoKB Level 3A. | standard breast therapy by subtype enhanced screening (annual MRI from age 40) |
|
| BIO-HRR-PANEL | PALB2 germline pathogenic | IIA |
| PALB2 germline pathogenic confers BRCA-like breast risk (~50% lifetime). Olaparib activity reported in PALB2-mutated breast (Tung TBCRC-048: ORR ~82% in HER2-negative metastatic, n=11) but PARPi labels in breast remain BRCA- only. NCCN lists PALB2 as a PARPi-eligible mutation off-label. ESCAT IIA / OncoKB Level 3A. | olaparib (off-label per NCCN, TBCRC-048 evidence) talazoparib (off-label) platinum-based chemo (TNBC) |
|
| BIO-HRR-PANEL | RAD51B germline pathogenic | IIIA |
| RAD51B germline pathogenic in breast: moderate-risk allele (~RR 2-4 for RAD51C/D, less established for RAD51B). No PARPi label; off-label consideration in HRD context. ESCAT IIB-IIIA / OncoKB Level 3B. | standard breast therapy PARPi off-label (HRD-positive context) |
|
| BIO-HRR-PANEL | RAD51C germline pathogenic | IIB |
Evidence cited from clinical guidelines; per-source evidence levels not yet structured. See Phase-2-of-CIViC-pivot for re-cite roadmap. | RAD51C germline pathogenic in breast: moderate-risk allele (~RR 2-4 for RAD51C/D, less established for RAD51B). No PARPi label; off-label consideration in HRD context. ESCAT IIB-IIIA / OncoKB Level 3B. | standard breast therapy PARPi off-label (HRD-positive context) |
|
| BIO-HRR-PANEL | RAD51D germline pathogenic | IIB |
| RAD51D germline pathogenic in breast: moderate-risk allele (~RR 2-4 for RAD51C/D, less established for RAD51B). No PARPi label; off-label consideration in HRD context. ESCAT IIB-IIIA / OncoKB Level 3B. | standard breast therapy PARPi off-label (HRD-positive context) |
|
| BIO-HRR-PANEL | RAD54L germline pathogenic | IIIA |
| RAD54L germline variants: rare; HR-pathway gene with limited clinical evidence. Included in some HRR panels but no labeled indication. ESCAT IIIA / OncoKB Level 4. | standard therapy PARPi off-label (HRD context only) |
|
| ID | Name | Priority | Category | Where to order | Needed for |
|---|---|---|---|---|---|
| TEST-CECT-CAP | CECT chest/abdomen/pelvis | Critical | imaging | — | standard |
| TEST-ER-PR-IHC | ER + PR immunohistochemistry on tumor | Critical | — | CSD Lab ✓ (code TBC) | standard |
| TEST-HER2-IHC-FISH | HER2 IHC + reflex FISH on tumor | Critical | — | CSD Lab ✓ (code TBC) | standard |
| TEST-GERMLINE-BRCA-PANEL | Germline BRCA1/2 + HRR panel sequencing | Standard | — | CSD Lab: M089 | standard |
| TEST-PIK3CA-NGS | PIK3CA mutation testing (tumor or ctDNA) | Standard | — | CSD Lab: M065 | desired (standard) |
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|---|---|---|---|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| NCT | Title | Phase | Status | Sponsor | UA | Eligibility (excerpt) |
|---|---|---|---|---|---|---|
| NCT06903468 | Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions | NA | RECRUITING | University of Florida | — | |
| NCT02422641 | Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis | PHASE2 | RECRUITING | Wake Forest University Health Sciences | — | |
| NCT06781281 | NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer. | N/A | RECRUITING | Henan Cancer Hospital | — | |
| NCT05919108 | Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers | PHASE2 | RECRUITING | Vanderbilt-Ingram Cancer Center | — | |
| NCT04437160 | Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy | PHASE2 | RECRUITING | Chinese Academy of Medical Sciences | — | |
| NCT03827317 | HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer | NA | RECRUITING | Imperial College London | — | |
| NCT05196087 | Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!) | N/A | RECRUITING | University Health Network, Toronto | — | |
| NCT04891068 | BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer | PHASE2 | RECRUITING | University of Illinois at Chicago | — | |
| NCT04553770 | Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer | PHASE2 | RECRUITING | Jonsson Comprehensive Cancer Center | — | |
| NCT04368702 | CONFIRM: Magnetic Resonance Guided Radiation Therapy | NA | RECRUITING | Brigham and Women's Hospital | — |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|---|---|---|---|
| Standard plan AI + ribociclib (HR+/HER2- metastatic 1L; OS-validated) (REG-AI-RIBOCICLIB) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan TCHP — docetaxel + carboplatin + trastuzumab + pertuzumab (HER2+ neoadjuvant) (REG-TCHP-NEOADJUVANT) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan THP — docetaxel + trastuzumab + pertuzumab (HER2+ metastatic 1L) (REG-THP-METASTATIC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan T-DXd monotherapy (HER2+ metastatic 2L+, also HER2-low metastatic) (REG-TDXD-METASTATIC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Pembrolizumab + chemo (TNBC neoadjuvant) (REG-PEMBRO-CHEMO-TNBC-NEOADJUVANT) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Olaparib monotherapy (BRCA-mutant HER2- breast: metastatic OR adjuvant high-risk early) (REG-OLAPARIB-BREAST) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| IND-BREAST-TNBC-METASTATIC-1L-PEMBRO-CHEMO — No regimen components on this track — availability unknown | — unknown | — unknown | ₴-? — verify pathway | not recorded |
| Trial · NCT06903468 Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT02422641 Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06781281 NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer. No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05919108 Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04437160 Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT03827317 HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05196087 Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04891068 BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04553770 Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04368702 CONFIRM: Magnetic Resonance Guided Radiation Therapy No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-04.